K931626 is an FDA 510(k) clearance for the CARAPACE STERILE COTTON BALLS. This device is classified as a Fiber, Medical, Absorbent (Class I - General Controls, product code FRL).
Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 2, 1993, 244 days after receiving the submission on April 2, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5300.
| 510(k) Number | K931626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1993 |
| Decision Date | December 02, 1993 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRL — Fiber, Medical, Absorbent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5300 |